Actively Recruiting
IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
Actinium Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.
CONDITIONS
Official Title
IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) after at least one prior chemoimmunotherapy including anthracycline and CD20 therapy
- Confirmed relapsed or refractory disease with biopsy within the last 12 months
- Age 18 years or older
- Creatinine clearance of 50 mL/min or higher
- Total bilirubin less than or equal to 1.5 times upper limit of normal; AST and ALT less than or equal to 3 times upper limit of normal (exceptions allowed)
- Adequate lung function with oxygen saturation of at least 92% on room air or per institutional guidelines
- Thyroid function tests within twice the upper limit of normal
- Adequate bone marrow function without recent blood product or growth factor support (neutrophils ≥1.0k/µL, platelets ≥50k/µL, hemoglobin ≥8 g/dL)
- ECOG performance status between 0 and 2
- Agreement to use contraception if of child-bearing potential during and for 30 days after study treatment
- Ability to understand and sign informed consent
- For patients receiving bridging therapy, meet key inclusion criteria within 10-14 days before planned 131I-Apamistamab infusion
You will not qualify if you...
- Pregnant or lactating patients
- Impaired heart function with left ventricular ejection fraction below 40%
- Active graft versus host disease requiring systemic T-cell suppressive therapy
- Active autoimmune disease requiring systemic T-cell suppressive therapy
- Severe heart conditions including NYHA stage III or IV heart failure, recent myocardial infarction within 6 months, or significant ventricular arrhythmia or unexplained syncope
- Positive tests for HIV, hepatitis B or C except certain vaccinated or resolved cases
- Uncontrolled systemic infections
- Concurrent active cancers requiring therapy other than hormone treatment or observation, excluding certain skin cancers
- History or presence of serious neurological disorders like epilepsy or severe brain injury
- Presence of human anti-mouse antibodies to BC8 prior to 131I-Apamistamab infusion
- Previous treatment with radiopharmaceuticals for lymphoma
- QTcF interval greater than 470 milliseconds on EKG
- Any other condition deemed by the physician to make the patient ineligible
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
F
Farrukh Awan, MD, MS, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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